目的建立高效液相色潽法测定苯甲酸阿格列汀有关物质含量的方法。方法采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);乙腈为流动相A,体积分数为0.05%的三氟乙酸为流动相B,流速为1.0 m L·min-1,梯度洗脱;检测波长为278 nm;进样量为20μL;柱温为30℃。结果苯甲酸阿格列汀与有关物质A~G及未知杂质均能良好分离;各有关物质的质量浓度在0.1~2.0 mg·L-1内线性关系良好,r≥0.994(n=8);回收率为96.4%~104.3%(RSD≤1.7,n=9)。经对三批样品测定,有关物质的含量质量分数均低于限度(0.1%)。结论作者建立的方法简便准确、专属性强且灵敏度高,可作为苯甲酸阿格列汀有关物质的测定方法。 Objective To establish a HPLC method for the determination of alogliptin benzoate related substances. Methods Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase A consisted of acetonitrile as mobile phase A, trifluoroacetic acid with volume fraction of 0.05% as mobile phase B and gradient elution with a flow rate of 1.0 mL · min -1. The detection wavelength was 278 nm; the injection volume was 20 μL; the column temperature was 30 ℃. Results The alogliptin benzoate was separated from the related substances A ~ G and unknown impurities. The linearity of each related substance was within 0.1 ~ 2.0 mg · L-1, r≥0.994 (n = 8). The recoveries ranged from 96.4% to 104.3% (RSD≤1.7, n = 9). After three batches of samples were determined, the content of the relevant substances mass fraction below the limit (0.1%). Conclusion The method established by the author is simple and accurate, strong specificity and high sensitivity, which can be used as the determination method of alogliptin benzoate related substances.